Z-0478-2013Class I

The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color...

Name: Z-0478-2013 The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color...
Creator: Verathon, Inc.
Published: 2012-10-25
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2012-10-25 / Terminated / root cause: design

FDA source

Verathon, Inc. began a recall of The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium... on 2012-10-25. FDA classified it as Class I and gives the reason as "Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0478-2013
Classification: Class I
Status: Terminated
Initiated: 2012-10-25
Posted: 2012-12-07
Terminated: 2013-09-27
Recalling firm: Verathon Inc.
Product: The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3 0574-0007, GVL 4 0574-0001, and GVL 5 0574-0030. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Verathon, sent an "URGENT - Medical Device Recall" letter dated October 25, 2012, to their consignees/cutomers. The letter described the product, problem, and actions to be taken. The customers were instructed to return the recalled blades back to Verathon and complete and return the Device Recall Notification Reply Form via fax to (425) 883-2896 or email: [email protected]. All returned products will be quarantined and will be destroyed later. Verathon will replace the affected video laryngoscope blade at no cost to customers. Customers in Canada and US with questions can call 800-331-2313. If you are located outside of the US or Canada, please call 425-867-1348.
Quantity in commerce: total 2710 units
Distribution: Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela.
Product codes and lots: Serial numbers range for GVL3: 0574-0007/ MD105000 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0478-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2013	Class I	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)